Multi-event July 2019 FDA Recall Drug by Pfizer Inc.
This Multi-event Class II drug recall was voluntarily initiated by Pfizer Inc. on July 9, 2019 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in United States, PR, and Guam and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1487-2019
Lack of Assurance of Sterility: Bags have the potential to leak.
07-09-2019
07-24-2019
280340 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
United States, PR, and Guam
10-27-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233.
Batch or Lot Expiration Information
Lot# s: 85-516-KL; 85-517-KL, Exp. 1JAN2020; 86-601-KL; 86-603-KL; 86-618-KL, Exp. 1FEB2020; 87-707-KL, Exp. 1MAR2020; 91-205-KL, Exp. 1JUL2020; 92-306-KL, Exp. 1AUG2020.
Recall Number: D-1486-2019
Lack of Assurance of Sterility: Bags have the potential to leak.
07-09-2019
07-24-2019
58200 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
United States, PR, and Guam
10-27-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028.
Batch or Lot Expiration Information
Lot# s: 86-615-KL, Exp. 1FEB2020; 87-701-KL, Exp. 1MAR2020; 90-114-KL, Exp. 1JUN2020
